NZ Skeptics Articles

Grandfathered Homeopathy

Mark Honeychurch - 7 July 2025

Nearly a decade ago, I was in a local pharmacy and noticed that they had a flyer for a Weleda product that was making some pretty strong claims.

So, I did what any red-blooded skeptic would do and submitted an Advertising Standards Authority (ASA) complaint about the product. My complaint said:

The Weleda website advertises a product called “Cold & Flu Drops” for which a recommendation is given to “Take at the onset of cold or flu to relieve symptoms - fever, muscle ache, headache, sore throat, sneezing and runny nose”. The ingredients of this product are all at 3x (a homeopathic notation meaning 1:1000 dilution) or less.

This claim of relief of symptoms of colds and flu is a therapeutic claim, making this advert fall under the ASA’s Therapeutic Products code. As such, the ad appears to breach Principle 2, as the claims made have not been substantiated and it seems unlikely that any homeopathic remedy has been conclusively shown to treat these symptoms.

The ad also breaches Principle 3, as it is socially irresponsible to make false claims about being able to treat the symptoms of these viral infections, which are very common ailments in New Zealand.

The ad also breaches Part B1 Requirement 3, as these claims are not truthful, and Requirement 4, as this advert is likely to mislead unwary members of the public who do not realise that there is no good evidence for the efficacy of homeopathy.

In response to my complaint, Weleda successfully argued that their Cold and Flu remedy had been approved by MedSafe, New Zealand’s “Medicines and Medical Devices Safety Authority” - and my complaint was not upheld. I found this pretty hard to believe, given that this is a homeopathic product - and it’s pretty well settled by now that homeopathy is ineffective. So I emailed MedSafe for clarification. And, as they should, MedSafe treated my email as an Official Information Act request:

Mark Honeychurch mark@honeychurch.org

Mon, 19 Sept 2016, 17:33

to askmedsafe

Hi,

In a recent Advertising Standards Authority complaint against Weleda’s Cold & Flu remedy, Weleda have defended their claims of the remedy’s efficacy by saying that the claims have been approved by MedSafe:

“Weleda Cold & Flu Drops is a registered medicine with Medsafe (TT50-8039) and is permitted to carry therapeutic claims. In relation to the complaint, the recommendations for the product on the website are consistent with the registered packaging indications which are as follows:

Take at the onset of cold or flu to relieve symptoms - fever, muscle ache, headache, sore throat, sneezing and runny nose.”

I have found the MedSafe registration of Weleda’s product at:

http://www.medsafe.govt.nz/regulatory/ProductDetail.asp?ID=13354

However, I’m having problems finding MedSafe’s approval for the specific therapeutic claims Weleda are making for their product.

Please could someone let me know if MedSafe have approved these therapeutic claims for Weleda’s homeopathic cold & flu remedy, and if so where I can find information on the approval.

It would be really useful if I could receive a response to my query as soon as possible, as the ASA have a very strict timeline for appealing against complaint decisions.

Thanks in advance.

Mark Honeychurch

Society for Science Based Healthcare

MedSafe’s response was, as is often the case, an unsearchable, scanned PDF. This has been pretty standard behaviour for government departments responding to OIA requests over the years, despite the Ombudsman’s instructions to ensure digital files are kept digital and not just turned into images. It was also disappointing in that it confirmed my worst fears, that Weleda were telling the truth and their homeopathic remedy had been approved for making claims.

Dear Mr Honeychurch

Re: Weleda Cold and Flu Drops

Thank you for your email correspondence dated 19 September and 27 September 2016 requesting information about the Cold and Flu Drops homoeopathic medicine distributed by Weleda.

For your convenience I have responded to your questions in the order posed.

1. What indications have Medsafe approved for Weleda’s Cold & Flu Drops?

This product is approved as a homoeopathic medicine for cold and flu relief for children to adults.

2. What substantiation, if any, was used to accept these indications, either when the product was “grandfathered” into Medsafe’s current registration system, or at any other time?

The product was grandfathered into the current regulatory scheme following the enactment of the Medicines Act 1981. Products that were eligible for grandfathering were those that were already marketed in New Zealand and had a demonstrated history of safe use. For grandfathered products, the date of approval was deemed to be the earliest date of market availability provided by the product owner.

The product was originally indicated as a homoeopathic medicine for all types of influenza and colds. These indications were accepted at the time.

Subsequent to the original approval under the Medicines Act the indications have been modified in 2007 and 2014. The modified indications have been accepted as they are all encompassed by the original approval.

3. When did the “grandfathering” occur?

Products that were marketed with an acceptable safety profile were grandfathered under the Medicines Act following enactment in 1981.

4. Does Medsafe consider that the approved indications are consistent with Weleda”s instructions to “take at the onset of cold or flu to relieve symptoms - fever, muscle ache, headache, sore throat, sneezing and runny nose”?

Medsafe agrees that this instruction is consistent with the approved indications for this homoeopathic medicine.

5. The ASA claim that the wording above was approved by Medsafe for Weleda’s packaging of their Cold & Flu Drops. Can you confirm that this is the case? If so, when was this approval given?

Please find attached the approved label for Weleda Cold and Flu Drops homoeopathic medicine. This label was approved in 2014.

6. What is the best way to find out indications that aren’t currently online for registered medicines? Are there plans to make these indications publicly available at some point in the future?

Medsafe has a current project to populate the therapeutic products data base with approved indications. Indications are added for new medicines upon approval and for existing products as resources permit.

The approved product details for any medicine included in the therapeutic products data base is available via the on-line search function at http://www.medsafe.govt.nz/requlatory/DbSearch.asp. Interested parties are welcome to contact Medsafe if the indication of interest has not yet been entered.

7. What other Weleda products, and homeopathic products from other manufacturers, are registered with Medsafe as medicines, and what indications are there for each of them?

You can search for Weleda’s approved medicines that have been transferred into the therapeutics data base using the search function above and entering Weleda into the sponsor box. Please note that products in the data base are those which have undergone regulatory activity since being grandfathered.

Weleda also notified over 1000 homoeopathic medicines to be grandfathered. The approved product details are only held in hard copy files. Many of the products are intended to be supplied to practitioners of homoeopathy or direct to patients through speciality retail stores.

Providing the requested information would require extensive research and collation and cannot be completed within the timeframe you have indicated is necessary for you to lodge an appeal to the Advertising Standards Authority.

If this information was requested under the Official Information Act 1982 it is likely that the request would be refused because Medsafe lacks the resource to undertake the substantial work required to provide the information requested.

You are welcome to use the search function above to identify products of interest and refine your request. You may also request information about specific Weleda products that are not identified in the data base. Your request is likely to be regarded as a request for official information.

Please note that many homoeopathic remedies are not distributed in New Zealand as approved medicines. Instead they are distributed using specific exemptions in the Medicines Act or as general consumer goods. Medsafe is only aware of Weleda having obtained consent to distribute a range of homoeopathic medicines.

8. What other Weleda products which are currently registered with Medsafe were “grandfathered” into the registration scheme?

The search results obtained as instructed above will include an approval date. Any product approved prior to 1981 is considered to be grandfathered. All other Weleda products notified in the hard copy files were grandfathered.

9. What process, if any, is there for deregistering a product that is currently registered with Medsafe?

The Medicines Act provides a mechanism whereby the Minister of Health may revoke consent (approval). Sponsors may also choose to voluntarily surrender consent. A copy of the Medicines Act may be downloaded for free from www.legislation.govt.nz

10. How would someone best go about reporting a product to Medsafe where the indications appear to be out of line with current best evidence?

Complaints about medicines may be submitted to the Manager of Compliance via this email address, recalls@moh.govt.nz

I trust this is the information you are seeking.

Yours sincerely

Alison Cossar

Acting Group Manager

Medsafe

What was really surprising here was that Weleda had over 1,000 of their homeopathic products registered as therapeutic products with allowable medical claims. How nobody in the Ministry of Health noticed and put the brakes on I really don’t know - I guess everyone was asleep at the wheel maybe? Despite being fairly confident that the ASA weren’t going to be swayed, I figured that it was worth a shot to appeal this decision. Here’s the appeal that I submitted:

I would like to appeal ASA case 16/283, on the grounds that evidence provided to the Complaints Board has been misinterpreted to the extent that it has affected the decision.

Weleda stated in their complaint response that their Cold and Flu Drops product is registered with Medsafe, with approval to make therapeutic claims about influenza and colds. This was the basis for their defence against breach of Principle 2, Principle 3, Part B1 Requirement 3 and Part B1 Requirement 4 (a) of the ASA’s Therapeutic Products code. This was the only defence of their claims that Weleda provided. No substantiation, in the form of scientific studies or other evidence, was submitted.

I have talked with Medsafe about Weleda’s registration for the Cold and Flu Drops. They told me that Weleda are correct in that “this product is approved as a homoeopathic medicine for Cold and flu relief for Children to adult”. This registration has been in place since 1981.

What Weleda have failed to mention to the ASA is that this registration came about due to a “grandfathering” process when the Medicines Act came into force, back in 1981. At this time, any products that had already been making therapeutic claims were able to gain registration and approval for those claims without having to provide substantiation. Medsafe said “The product was grandfathered into the current regulatory scheme following the enactment of the Medicines Act 1981. Products that were eligible for grandfathering were those that were already marketed in New Zealand and had a demonstrated history of safe use”. The grandfathering focused only on safety, and did not evaluate efficacy.

Subsequent modifications to Weleda’s Medsafe registration for their Cold and Flu Drops have had a similar lack of requirement for evidence of efficacy. Medsafe considered those changes to be within the scope of the original grandfathered set of claims - “The modified indications have been accepted as they are all encompassed by the original approval.”

As a “grandfathered” product, this Medsafe registration is not evidence of efficacy. However, Weleda have misrepresented their product registration as evidence of efficacy by claiming in their complaint response that “Given that the statement on the website is consistent with the registered indications, we consider that the claims do not contravene the Therapeutic Products Advertising Code.”

The specific parts of the code that Weleda claim their Medsafe registration covers them for are:

These codes require substantiation - Principle 2 and Part B1 Requirement 3 explicitly state that adverts “must” be “truthful” and make claims that are “valid” and that have been “substantiated”. If Weleda’s claims are not backed by high quality evidence of efficacy, regardless of their “grandfathered” product registration with Medsafe, these claims are irresponsible (Principle 3) because they are likely to mislead (Part B1 Requirement 4 (a)).

The Medsafe registration defence that Weleda has given would appear to be relevant to Principle 1 of the Therapeutic Products Code (“Advertisements must comply with the laws of New Zealand”). However, breach of this Principle was not part of the original complaint and so their defence is irrelevant to this complaint.

Therefore, unless Weleda are able to provide evidence that their Cold and Flu Drops are able to “relieve symptoms – fever, muscle ache, headache, sore throat, sneezing and runny nose”, I believe that this product is in breach of Principle 2, Principle 3, Part B1 Requirement 3 and Part B1 Requirement 4 (a) of the ASA’s Therapeutic Products Code.

If Weleda provide evidence in their appeal response to back up the therapeutic claims they make about their Cold and Flu Drops, I would appreciate being given the chance to submit a further document where I am able to critically evaluate their evidence. Obviously I am not able to assess Weleda’s evidence yet, as they did not provide any in their complaint response. If this is not possible, please let me know so that I can provide a summary of the scientific evidence most relevant to their claims.

Speaking in general terms about evidence, I can briefly say that I have spent time looking for evidence that homeopathic products are able to treat any medical condition better than placebo, and have so far come to the same conclusion as many major medical research organisations around the world. This is nicely summarised by Australia’s NHMRC, who said recently that “there are no health conditions for which there is reliable evidence that homeopathy is effective”.

Unsurprisingly the appeal was unsuccessful. I’m still incensed that the government of the day thought that it was okay to allow pharmaceutical companies and alternative medicine manufacturers to register allowed therapeutic benefit claims simply based on a) a history of making those claims and b) a track record of the products being safe. They seem to have missed the gaping hole in this scheme that ineffective sugar pills like homeopathy might be safe, but they’re also totally ineffective - despite any dubious claims the companies selling them might have made to the contrary.

If you want to read the complaint and appeal in their entirety, including Weleda, the ASA and MedSafe’s input, you can read it here on the NZLII website. The NZLII (NZ Legal Information Institute) does a great job of archiving ASA complaints, aṡ well as many other important repositories of legal information, so thankfully complaints like mine get to live on beyond the limited seven year lifespan that they have being hosted by organisations like the ASA.